Wearable Activity Tracking to Curb Hospitalizations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-07

Study Completion Date

2027-12-31

Brief Summary

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This study is being done to collect patient generated health data to predict the risk of patients needing emergency department visits or hospitalization before, during. and after receiving radiation therapy.

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Detailed Description

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PRIMARY OBJECTIVE:

I. Validate a previously developed step-count model for predicting all-cause acute care (pooled across all devices).

SECONDARY OBJECTIVES:

I. Validate a previously developed model for predicting each ED visits or hospitalizations during external beam RT using continuous step counts before, during, and after treatment.

II. Validate the previously developed step-count model for predicting all-cause acute care for each of the two different device platforms.

III. Validate concordance of step counts across each of the device's platforms in the Apple group.

IV. Validate the previously developed SHIELD-RT Electronic health record (EHR)-based model for predicting unplanned acute care (ED visit or hospitalization).

EXPLORATORY OBJECTIVES:

I. Refinement of the pre-existing models(step count and SHIELD-RT). II. Evaluate association between wearables collected parameters, EHR-based variables, and acute care events.

III. Develop and validate a multi-modal predictive model for predicting acute care.

OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.

* GROUP I: Participants receive Fitbit device and undergo non-interventional, standard of care, radiation therapy.
* GROUP II: Participants receive Fitbit device and utilize their own personal Apple HealthKit-based device and undergo non-interventional, standard of care, radiation therapy.

Conditions

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Hematopoietic Neoplasm Malignant Solid Neoplasm Lymphatic System Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational Group I: Fitbit only

Participants receive Fitbit device while undergoing non-interventional, standard of care, radiation therapy.

Fitbit

Intervention Type DEVICE

Participants will wear Fitbit device

Observational Group II: Fitbit + Apple HealthKit

Participants receive Fitbit device and will utilize personal Apple HealthKit-based devices (iPhone, Apple Watch, etc.) to concurrently contribute Apple HealthKit-based data while undergoing non-interventional, standard of care, radiation therapy.

Fitbit

Intervention Type DEVICE

Participants will wear Fitbit device

Apple HealthKit-based devices

Intervention Type DEVICE

Participants will wear personal device and share data with study team.

Interventions

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Fitbit

Participants will wear Fitbit device

Intervention Type DEVICE

Apple HealthKit-based devices

Participants will wear personal device and share data with study team.

Intervention Type DEVICE

Other Intervention Names

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Wearable Activity Tracker iPhone Apple watch

Eligibility Criteria

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Inclusion Criteria

* Age \>= 18.
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2.
* Able to understand study procedures and to comply with them for the entire length of the study.
* Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
* Diagnosis of invasive malignancy.
* Able to ambulate independently (without the assistance of a cane or walker).
* Planned treatment with fractionated external beam radiotherapy over at least 5 days (no fractional requirement).
* Not a previous participant on this protocol for subsequent courses.